System and method for modulated surgical procedure irrigation and aspiration

ABSTRACT

A method and apparatus for performing modulated fluid delivery and aspiration during a surgical procedure such as phacoemulsification is provided. The method and apparatus include delivering fluid and/or aspirating fluid in a modulated or pulsed manner during a surgical procedure, including applying fluid and/or aspirating fluid in connection with ultrasonic energy at a level and for a time period sufficient to induce transient cavitation. Fluid may be applied and/or aspirated at a timing sequence and duty cycle similar to or different from application of ultrasonic energy delivery.

This application is a divisional of co-pending U.S. patent applicationSer. No. 12/927,631, entitled “System and Method for Modulated SurgicalProcedure Irrigation and Aspiration,” inventors Mark E. Steen et al.,filed Nov. 18, 2010, which is a divisional of co-pending U.S. patentapplication Ser. No. 10/619,088, entitled “System and Method forModulated Surgical Procedure Irrigation and Aspiration,” inventors MarkE. Steen et al., filed Jul. 14, 2003, now U.S. Pat. No. 7,846,126, theentirety of both of which are hereby incorporated by reference.

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates generally to the field of surgical tissueremoval systems, and more specifically to modulated irrigation andaspiration during surgical procedures such as phacoemulsification.

Description of the Related Art

Phacoemulsification surgery has been successfully employed in thetreatment of certain ocular problems, such as cataracts.Phacoemulsification surgery utilizes a small corneal incision to insertthe tip of at least one phacoemulsification handheld surgical implement,or handpiece. The handpiece includes a needle which is ultrasonicallydriven once placed within an incision to emulsify the eye lens, or breakthe cataract into small pieces. The broken cataract pieces maysubsequently be removed using the same handpiece or another handpiece ina controlled manner. The surgeon may then insert lens implants in theeye through the incision. The incision is allowed to heal, and theresults for the patient are typically significantly improved eyesight.

As may be appreciated, the flow of fluid to and from a patient through afluid infusion or extraction system and power control of thephacoemulsification handpiece is critical to the procedure performed.Different medically recognized techniques have been utilized for thelens removal portion of the surgery. Among these, one popular techniqueis a simultaneous combination of phacoemulsification, irrigation andaspiration using a single handpiece. This method includes making theincision, inserting the handheld surgical implement to emulsify thecataract or eye lens. Simultaneously with this emulsification, thehandpiece provides a fluid for irrigation of the emulsified lens and avacuum for aspiration of the emulsified lens and inserted fluids.

Currently available phacoemulsification systems include a variable speedperistaltic pump, a vacuum sensor, an adjustable source of ultrasonicpower, and a programmable microprocessor with operator-selected presetsfor controlling aspiration rate, vacuum and ultrasonic power levels. Aphacoemulsification handpiece is interconnected with a control consoleby an electric cable for powering and controlling the piezoelectrictransducer. Tubing provides irrigation fluid to the eye and enableswithdrawal of aspiration fluid from an eye through the handpiece. Thehollow needle of the handpiece may typically be driven or excited alongits longitudinal axis by the piezoelectric effect in crystals created byan AC voltage applied thereto. The motion of the driven crystal isamplified by a mechanically resonant system within the handpiece suchthat the motion of the needle connected thereto is directly dependentupon the frequency at which the crystal is driven, with a maximum motionoccurring at a resonant frequency. The resonant frequency is dependentin part upon the mass of the needle interconnected therewith, which istypically vibrated by the crystal.

Power control of the phacoemulsification handpiece is highly critical tosuccessful phacoemulsification surgery. Certain previous systems addressthe requirements of power control for a phacoemulsification handpiecebased on the phase angle between voltage applied to a handpiecepiezoelectric transducer and the current drawn by the piezoelectrictransducer and/or the amplitude of power pulses provided to thehandpiece. The typical arrangement is tuned for the particularhandpiece, and power is applied in a continuous fashion or series ofsolid bursts subject to the control of the surgeon/operator. Forexample, the system may apply power for 150 ms, then cease power for 350ms, and repeat this on/off sequence for the necessary duration of powerapplication. In this example, power is applied through the piezoelectriccrystals of the phacoemulsification handpiece to the needle causingultrasonic power emission for 150 ms, followed by ceasing application ofpower using the crystals, handpiece, and needle for 350 ms. It isunderstood that while power in this example is applied for 150 ms, thisapplication of power includes application of a sinusoidal waveform tothe piezoelectric crystals at a frequency of generally between about 25kHz and 50 kHz and is thus not truly “constant.” Application of powerduring this 150 ms period is defined as a constant application of a 25kHz to 50 kHz sinusoid. In certain circumstances, the surgeon/operatormay wish to apply these power bursts for a duration of time, ceaseapplication of power, then reapply at this or another power setting. Thefrequency and duration of the burst is typically controllable, as is thelength of the stream of bursts applied to the affected area. The timeperiod where power is not applied enable cavitation in the affected areawhereby broken sections may be removed using aspiration provided by thehandpiece or an aspiration apparatus.

As described in U.S. patent application Ser. No. 10/387,327 toKadziauskas et al., entitled “System and Method for Pulsed UltrasonicPower Delivery Employing Cavitation Aspects,” filed Mar. 12, 2003,discusses the beneficial aspects of transient cavitation and provides asystem and method for applying energy at a level and for a time periodsufficient to induce transient cavitation, and reducing applied energyafter applying energy during a second nonzero lower energy period.Various ultrasonic power delivery profiles may be employed utilizing thebeneficial effects of transient cavitation, including more powerfulremoval with reduced risk of burning or damaging the affected area.

Generally, irrigation and aspiration are employed by the surgeon usingthe device to remove unwanted tissue and maintain pressure within theeye. In the presence of high frequency power applications, cavitationmay be generated through the needle to the unwanted tissue in an effortto break the tissue. Alternately, mechanical fragmentation may beemployed using rotary, oscillatory, or reciprocating cutters to segmentor grind unwanted tissue. The resultant tissue is aspirated in slurryform from the surgical site.

Issues associated with aspiration and irrigation in this environment caninclude difficulty in acquiring or purchasing the tissue and holding thetissue with the tip for proper removal. Use of pulsed ultrasonic powerdelivery, and capture and removal of unwanted tissue, particularly inhigh power environments where transient cavitation is encountered, canbe difficult. Power delivery in the presence of relatively constant orslowly changing fluid flow characteristics can cause disruption ofpurchase, holding, and removal of unwanted tissue. Additionally, amechanical cavity or cavitation cloud may form in the presence ofultrasonic cavitational energy, and such a mechanical cavity can providea virtual barrier to efficient tissue processing. Such a mechanicalcavity results from pressure differentials formed by ultrasonic energyapplication in the presence of a relatively constant fluid flow, and isundesirable.

Further, in the environment described, tissue may occasionally clog thelumen, or fluid passage, within the tip of the handpiece. Such cloggingcreates unpredictable performance characteristics and can result inundesirable pressure surges. The vacuum levels typically employed withaspiration and irrigation tend to be low to avoid clogging and otherundesirable fluid flow effects. Use of low pressure can inhibit asurgeon's ability to purchase and hold unwanted tissue.

Based on the foregoing, it would be advantageous to provide anirrigation and aspiration system that effectively and efficientlyoperates in the presence of high ultrasonic power delivery, such assystems generating transient cavitation, and minimizes those drawbacksassociated with previous tissue removal systems.

SUMMARY OF THE INVENTION

According to a first aspect of the current design, there is provided anapparatus comprising a handpiece having a needle and electrical meansfor ultrasonically vibrating said needle, power source means forproviding pulsed electrical power to the handpiece electrical means,input means for enabling an operator to select an amplitude of theelectrical pulses, irrigation means for providing fluid during asurgical procedure conducted in a surgical environment, said irrigationmeans providing fluid during at least one modulated fluid burst period,said modulated fluid burst period comprising a fluid pulse within thesurgical environment, followed by a de minimis fluid pulse, and controlmeans for controlling power supplied to the handpiece.

According to a second aspect of the current design, there is provided anapparatus comprising a handpiece having a needle and electrical meansfor ultrasonically vibrating said needle, power source means forproviding pulsed electrical power to the handpiece electrical means,input means for enabling an operator to select an amplitude of theelectrical pulses, irrigation means for providing fluid from thehandpiece, said fluid providing means controlling fluid provided byapplying fluid for a fluid pulse period followed by applying de minimisfluid during a fluid pause period, and control means for controllingpower supplied to the handpiece.

According to a third aspect of the current design, there is provided amethod for delivering fluid to an ocular region during aphacoemulsification procedure. The method comprises irrigating theocular region by applying a series of modulated fluid pulses to theocular region via a fluid control device.

According to a fourth aspect of the current design, there is provided amethod of delivering fluid to a region during a tissue removalprocedure, comprising delivering modulated fluid pulses during an onperiod, fluid pulse delivery comprising delivering at least one pulse offluid having a relatively high amplitude, and delivering a de minimisquantity of fluid after delivering every high amplitude fluid pulse.

According to a fifth aspect of the current design, there is provided asurgical apparatus. The surgical apparatus comprises means for applyingfluid to an area. The applying means comprise irrigation means forapplying modulated fluid pulses during a plurality of short burstperiods, said short burst periods comprising a fluid burst periodfollowed a predetermined time thereafter by a de minimis fluid deliveryperiod.

According to a sixth aspect of the current design, there is provided amethod for providing modulated fluid pulses to an ocular region during aphacoemulsification procedure. The method comprises applying fluid tothe ocular region using at least one modulated fluid pulse period. Eachmodulated fluid pulse period comprises applying fluid to the ocularregion using a fluid pulse for a first period of time, and applying deminimis fluid to the ocular region for a second period of time.

According to a seventh aspect of the current design, there is provided amethod for providing fluid during a surgical procedure. The methodcomprises providing fluid using a fluid control device during aplurality of pulse periods, said pulse periods comprising a fluid surgeperiod followed by a fluid pause period, wherein fluid applied duringthe fluid surge period is greater than fluid applied during the fluidpause period.

According to an eighth aspect of the current design, there is providedan apparatus comprising a handpiece having a needle and electrical meansfor ultrasonically vibrating the needle, power source means forproviding pulsed electrical power to the handpiece electrical means,input means for enabling an operator to select an amplitude of theelectrical pulses, aspiration means for aspirating fluid during asurgical procedure conducted in a surgical environment, the aspirationmeans receiving fluid during at least one modulated fluid burst period,the modulated fluid burst period comprising a negative pressuredifferential pulse delivered to the surgical environment, followed by ade minimis pressure differential pulse transmission; and control meansfor controlling power supplied to the handpiece.

According to a ninth aspect of the current design, there is provided amethod for aspirating fluid from an ocular region during aphacoemulsification procedure. The method comprises aspirating theocular region by applying a series of modulated differential pressurepulses to the ocular region via a fluid control device.

According to a further aspect of the current design, there is providedan apparatus comprising a handpiece having a needle and electrical meansfor ultrasonically vibrating said needle, a power source configured toprovide pulsed electrical power to the handpiece, a controllerconfigured to enable an operator to select and control an amplitude ofelectrical pulses provided by the power source, and an irrigationcontrol device configured to aspirate fluid during a surgical procedureconducted in a surgical environment, said irrigation control deviceconfigured to receive fluid during at least one modulated fluid burstperiod, said modulated fluid burst period comprising a negative pressuredifferential pulse delivered to the surgical environment, followed by ade minimis pressure differential pulse transmission.

These and other objects and advantages of all aspects of the presentdesign will become apparent to those skilled in the art after havingread the following detailed disclosure of the preferred embodimentsillustrated in the following drawings.

DESCRIPTION OF THE DRAWINGS

The present invention is illustrated by way of example, and not by wayof limitation, in the figures of the accompanying drawings in which:

FIG. 1 is a functional block diagram of a prior art phacoemulsificationsystem;

FIG. 2 is a functional block diagram of an alternative aspect of a priorart phacoemulsification system including apparatus for providingirrigation fluid at more than one pressure to a handpiece;

FIG. 3A is a functional block diagram of a phacoemulsification systemhaving the ability to provide modulated irrigation and/or aspiration inaccordance with one aspect of the present invention;

FIG. 3B is a functional block diagram of a phacoemulsification systemincluding apparatus for providing irrigation fluid at more than onepressure to a handpiece and having the ability to provide modulatedirrigation and/or aspiration in accordance with another aspect of thepresent invention;

FIG. 4 illustrates a sample aspiration/irrigation control unit;

FIGS. 5A, 5B, and 5C show a rotary fluid control device according to oneaspect of the present design;

FIGS. 6A, 6B, and 6C illustrate another fluid control device accordingto another aspect of the present design;

FIGS. 7A, 7B, and 7C show yet another fluid control device according toyet another aspect of the present design;

FIGS. 8A, 8B, and 8C present still another fluid control deviceaccording to still another aspect of the present design;

FIGS. 9A, 9B, 9C, and 9D present a further fluid control deviceaccording to a further aspect of the present design;

FIGS. 10A and 10B illustrate a stretching type fluid control design inaccordance with another aspect of the present design;

FIGS. 11A and 11B represent a hammer type fluid control design inaccordance with another aspect of the present design;

FIGS. 12A and 12B present a single hammer conceptual illustration inaccordance with another fluid control aspect of the present design;

FIGS. 13A and 13B show a dual hammer conceptual illustration inaccordance with another fluid control aspect of the present design;

FIGS. 14A and 14B illustrate an alternate hammer design in accordancewith another fluid control aspect of the present design;

FIG. 15 is a flow chart illustrating the operation of a variable dutycycle pulse function of the ultrasound energy delivery aspect of thephacoemulsification system;

FIG. 16 is a flow chart illustrating the operation of theoccluded-unoccluded mode of the ultrasound energy delivery aspect of thephacoemulsification system with variable irrigation rates, includingpulsed fluid delivery;

FIG. 17 is a plot of the phase relationship of ultrasound energydelivery as a function of frequency for various handpiece/needleloading;

FIG. 18 is a function block diagram of phase control ultrasound energydelivery in a phacoemulsification system utilizing phase angles tocontrol handpiece/needle parameters with max phase mode operation;

FIG. 19 is a function block control diagram of a phase controlultrasound energy delivery in a phacoemulsification system utilizingphase angles to control handpiece/needle parameters with a load detectmethod;

FIG. 20 presents a conceptual block diagram of computation and deliveryof an enhanced ultrasonic energy waveform; and

FIG. 21 is a function block control diagram of a pulse controlphacoemulsification system with normal ultrasonic energy waveforms.

DETAILED DESCRIPTION OF THE INVENTION

Device.

FIG. 1 illustrates a phacoemulsification system in block diagram form,indicated generally by the reference numeral 10. The system has acontrol unit 12, indicated by the dashed lines in FIG. 1 which includesa variable speed peristaltic pump 14, which provides a vacuum source, asource of pulsed ultrasonic power 16, and a microprocessor computer 18that provides control outputs to pump speed controller 20 and ultrasonicpower level controller 22. A vacuum sensor 24 provides an input tocomputer 18 representing the vacuum level on the input side ofperistaltic pump 14. Suitable venting is provided by vent 26.

A phase detector 28 provides an input to computer 18 representing aphase shift between a sine wave representation of the voltage applied toa handpiece/needle 30 and the resultant current into the handpiece 30.The block representation of the handpiece 30 includes a needle andelectrical means, typically a piezoelectric crystal, for ultrasonicallyvibrating the needle. The control unit 12 supplies power on line 32 to aphacoemulsification handpiece/needle 30. An irrigation fluid source 34is fluidly coupled to handpiece/needle 30 through line 36. Theirrigation fluid and ultrasonic power are applied by handpiece/needle 30to a patient's eye, or affected area or region, indicateddiagrammatically by block 38, and may include a lumen (not shown).Alternatively, the irrigation source may be routed to the eye 38 througha separate pathway independent of the handpiece. The eye 38 is aspiratedby the control unit peristaltic pump 14 through line/handpiece needle 40and line 42. A switch 43 disposed on the handpiece 30 may be utilized asa means for enabling a surgeon/operator to select an amplitude ofelectrical pulses to the handpiece via the computer 18, power levelcontroller 22 and ultrasonic power source 16 as discussed herein. Anysuitable input means, such as, for example, a foot pedal (not shown) maybe utilized in lieu of the switch 43.

FIG. 2 shows an alternative phacoemulsification system 50 incorporatingall of the elements of the system 10 shown in FIG. 1, with identicalreference characters identifying components, as shown in FIG. 1. Inaddition to the irrigation fluid source 34, a second irrigation fluidsource 35 is provided with the sources 34, 35 being connected to theline 36 entering the handpiece/needle 30 through lines 34 a, 35 a,respectively, and to a valve 59. The valve 59 functions to alternativelyconnect line 34A and source 34 and line 35A and source 35 with thehandpiece/needle 30 in response to a signal from the power levelcontroller 22 through a line 52.

As shown, irrigation fluid sources 34, 35 are disposed at differentheights above the handpiece/needle 30 providing a means for introducingirrigation fluid to the handpiece at a plurality of pressures, the headof the fluid in the container 35 being greater than the head of fluid inthe container 34. A harness 49, including lines of different lengths 44,46, when connected to the support 48, provides a means for disposing thecontainers 34, 35 at different heights over the handpiece/needle 30.

The use of containers for irrigation fluids at the various heights isrepresentative of the means for providing irrigation fluids at differentpressures, and alternatively, separate pumps may be provided with, forexample, separate circulation loops (not shown). Such containers andpumps can provide irrigation fluid at discrete pressures to thehandpiece/needle 30 upon a command from the power controller 22.

Operation.

The present design, shown in FIG. 3A, generates a pulse assistedwaveform either in phase or out of phase with the ultrasonic powersource 316 as monitored and provided by computer 318. The pulsedirrigation uses irrigation fluid generated by irrigation fluid source334 in a pulsing manner, timed to propagate the length of the tubing 336between the irrigation fluid source 334 and handpiece 330 and arrive atthe tip-tissue interface either randomly or in sequence or collaborationwith the modulated ultrasonic action.

From FIG. 3A, system 300 includes a control unit 312 having a variablespeed peristaltic pump 314, which provides a vacuum source, a source ofpulsed ultrasonic power 316, and a microprocessor computer 318 thatprovides control outputs to pump speed controller 320, ultrasonic powerlevel controller 322, and irrigation control unit 380. Vacuum sensor 324provides an input to computer 318 representing the vacuum level on theinput side of peristaltic pump 314. Suitable venting is provided by vent326.

Phase detector 328 provides an input to computer 318 representing aphase shift between a sine wave representation of the voltage applied toa handpiece/needle 330 and the resultant current into the handpiece 330.The block representation of the handpiece 330 again includes a needleand electrical means for ultrasonically vibrating the needle. Thecontrol unit 312 supplies power on line 332 to a phacoemulsificationhandpiece/needle 330. An irrigation fluid source 334 is fluidly coupledto handpiece/needle 330 through line 336. The irrigation fluid andultrasonic power are applied by handpiece/needle 330 to a patient's eye,or affected area or region, indicated diagrammatically by block 338.Alternatively, the irrigation source may be routed to the eye 338through a separate pathway independent of the handpiece. The eye 338 isaspirated by the control unit peristaltic pump 314 throughline/handpiece needle 340 and line 342, as controlled by irrigationcontrol unit 380. A switch 343 disposed on the handpiece 330 may enablethe surgeon/operator to select an amplitude of electrical pulses andcorresponding irrigation/aspiration pulses to the handpiece 330 via thecomputer 318, power level controller 322 and ultrasonic power source316. Again, any suitable input means, such as, for example, a foot pedal(not shown) may be utilized in lieu of the switch 343.

Fluid is aspirated from the eye 338 via aspiration line 340 andhandpiece 330. Aspirated fluid may pass to aspiration control unit 381,and from aspiration control unit 381 to peristaltic pump 314, phasedetector 328, vent 326, and vacuum sensor 347. Aspiration control unit381 is controlled by computer 318. Aspiration control unit 381 canprovide a series of pressure differential pulses, the pressuredifferential being between ambient pressure and a negative pressure,thereby propagating through handpiece 330 and aspiration line 340 andpulling fluid from the eye 338.

Pulsed fluid delivery and/or pressure differential pulses operate inconjunction with ultrasonic power delivery in the following manner.Ultrasonic power delivery may cause transient cavitation, defined as theviolent collapse of bubbles in the fluid. The system applies ultrasonicpower in brief pulses, with these brief pulses having divided energylevels for the phaco environment presented above. In particular, aninitial energy period sufficient to induce transient cavitation in theenvironment, such as ultrasonic power applied at 30 watts for a briefduration, such as 2 ms, may be employed. The 30 watts represents inputto the handpiece. Power may, in certain circumstances, be deliveredduring a second or subsequent energy delivery period, such as, forexample, power delivered at 15 watts for a period of 2 ms. However, asingle pulse sufficient to induce transient cavitation, followed by apower off period, may be the ultrasonic power profile delivered to thesite. Also, a third or subsequent lower energy delivery period may beemployed. The goal of the modulated or stepped power deliveryarrangement in this power delivery scenario is to initiate needle strokeabove the distance necessary to generate transient cavitation as rapidlyas possible. Once the power threshold required to induce transientcavitation has been achieved, power may be reduced for the remainder ofthe pulse.

FIG. 3B shows an alternative phacoemulsification system 350incorporating all of the elements of the system 310 shown in FIG. 3A,with identical reference characters identifying components. In additionto the irrigation fluid source 334, a second irrigation fluid source 335is provided with the sources 334, 335 being connected to the line 36entering the handpiece/needle 330 through lines 334 a, 335 a,respectively, and to a valve 359. Fluid flowing from valve 359 iscontrolled by irrigation control unit 380 via computer 318. The valve359 in combination with irrigation control unit 380 functions toalternatively connect line 334A to source 334 and line 335A to source335 with the handpiece/needle 330 in response to a signal from the powerlevel controller 322 through line 352.

As shown, irrigation fluid sources 334, 335 are disposed at differentheights above the handpiece/needle 330 providing a means for introducingirrigation fluid to the handpiece at varying pressures, the head of thefluid in the container 335 being greater than the head of fluid in thecontainer 334. A harness 349, including lines of different lengths 344,346, when connected to the support 348, provides a means for disposingthe containers 334, 335 at different heights over the handpiece/needle330. Aspiration may optionally operate in a similar manner to that shownin FIG. 3A.

Fluid is provided in a pulsed manner using the irrigation control unitor control device, which regulates fluid flow, particularly fluid pulsetiming. Aspiration is provided in a pulsed manner as well, using theaspiration control unit or control device, which regulates fluid flow byintroducing pressure differentials to the aspiration line. While thefollowing description is directed to modulated delivery of pulses inirrigating the area, similar control devices may be employed inaspirating fluid from the region. The control devices used to irrigatemay be employed to aspirate in a modulated manner as described above.

While both FIG. 3A and FIG. 3B illustrate modulated irrigation andaspiration elements 380 and 381 in dashed lines to indicate that theyare optional elements, it is to be understood that either aspirationand/or irrigation may be employed in accordance with the presentinvention, but that at least one of the irrigation control unit 380 andaspiration control unit 381 is to be employed. For example, themodulated aspiration described herein may be employed without modulatedirrigation and in the absence of irrigation control unit 380. In such animplementation, handpiece 330 would receive fluid either directly fromcontainer 334 or valve 359 without the need for connection to computer318. Similar alterations may be required if modulated irrigation isemployed in the absence of modulated aspiration.

One aspect of the computer controlled irrigation control unit ispresented in FIG. 4. From FIG. 4, the irrigation control unit 380 mayhave three small flexible tubes 401, 402, and 403 that may beindividually molded or formed together and terminate in a manifold 404to form a parallel flow path. Each of the three flow routes may have amechanism attached thereto, such as mechanism 404, 405, and/or 406.These mechanisms may be rotary pinch mechanisms or hammer mechanisms asdescribed below, or some other device capable of pulsing fluid at arelatively rapid rate. Each mechanism 404, 405, and 406 has the abilityto generate a pulse wave form source, or restrict and permit flowalternately within a relatively short period of time. The pulse waveform propagates the length of tubing 336. The effective frequency of thepressure pulse corresponds to desired action at the tip of the handpiece330. Pressure waves may be linked in phase with the ultrasonic powerdelivery or may operate at the harmonic frequency or frequencies of thesystem or handpiece 330. One timing scheme that may be employed at theaspiration/irrigation control unit 380 is a pulse source set at 120degrees out of phase, thereby generating a three phase pulse train.Alternately, the irrigation control unit 380 may employ asymmetric pulsemodes to enhance traction or disruption at the tip. Further, multipletube/valve arrangements may be employed to vary the flow to the eye andenhance the aforementioned effects. Such a device may alternately beemployed on the aspiration side of the system.

Control of the flow (irrigation or aspiration) through any or all of thesmall flexible tubes may be performed by various devices. One suchdevice is shown in FIGS. 5A, 5B, and 5C, which rotates at a ratecommanded by the computer. As shown in FIGS. 5A, 5B, and 5C, fourelements 501, 502, 503, and 504 may be employed, but three, five, ormore or less pinching elements may be used. FIG. 5A is a top view of acontrol device 500 with the tube 505 pinched by element 501. FIG. 5B isa top view of the same device 500 unpinched by any element. As withother designs for the control device presented herein, the tube 505 maybe constructed from standard material, such as a high strength plastictubing having sufficient elasticity. The parts of the device 500 such asthe element may be constructed of a high strength and high densityplastic, or another suitable material, including but not limited tometal. The functionality of the elements is the ability to cause closureor pinching of the tubing in the environment discussed. Note that asupport element 509 may be provided to facilitate holding or maintainingof the tubing while pinching occurs. FIG. 5C is a side view of thedevice 500 having a rotating support member or stepper motor 506 and topelement or pump head 507.

FIGS. 6A, 6B, and 6C illustrate an alternate design of a control device600. FIG. 6A illustrates the rotating pinching by member 601 of tube605. FIG. 6B shows the member 601 in horizontal position, not pinchingthe tube 605. FIG. 6C illustrates a side view of the control device 600with member 601 in a generally parallel orientation to tube 605 similarto the orientation of FIG. 6B. The design of FIGS. 6A, 6B, and 6Cfurther illustrates a pump head 607, rotating support member or steppermotor 606, and support element 609. FIG. 7A shows a single rotatingmember 701 able to restrict flow in two tubes 705 and 715. The rotatingmember 701 may have a center point 702 as well as two opposing rigidinserts 703 and 704. The rotating member 701 may be formed of plastic,while the rigid inserts 703 and 704 may be cylindrical or nearcylindrical metal insert pieces. Other materials may be used thatperform the required functionality and are appropriate for theenvironment. FIG. 7B shows the control device 700 in a non contactorientation. FIG. 7C is a side view of the control device 700 with asingle tube 705 in place and shows rotating element 706. A two piecesupport element 709 is presented here, which may or may not be employeddepending on circumstances.

FIGS. 8A, 8B, and 8C show a control device 800 that clamps the tubingfrom a relative outside position. Rotating element 801 includes asupport member 802 that sits below the two tubes 805 and 815, and arepinched by vertical elements 803 and 804. FIG. 8B shows the controldevice 800 in a non contact orientation. FIG. 8C is a side view ofcontrol device 800 showing rotating support member or stepper motor 806.Again, vertical elements 803 and 804 may be formed of any materialsufficient to deform the tubing. A rigid support wall (not shown) may beprovided between tubes 805 and 815 to provide support when pinching.

FIGS. 9A, 9B, 9C, and 9D illustrate another aspect of a control device900 for providing modulated irrigation and aspiration. Control device900 provides for dual pinching orientations which may facilitateaspiration and irrigation in certain instances. FIG. 9A shows dual pinchmember 901 pinching two tubes 905 and 915 and having center point 902and rigid elements 903 and 904. Support may be provided such as in theform of support members 906 and 907. FIG. 9B shows the control device inthe relaxed or non-pinching state. FIG. 9C illustrates the alternatepinching orientation. FIG. 9D illustrates a side view of control device900 including rotating support member or stepper motor 916.

FIGS. 10A and 10B illustrate a tube stretching design for a controldevice 1000 using a fixed piece 1001 and a movable piece 1002. Themovable piece is affixed or fixedly mounted to a slidable element orplunger 1003 that slides along a sleeve 1004 to stretch the tubing 1005.FIG. 10A illustrates an unstretched aspect of the design, while FIG. 10Bshows a fully extended version of the design. As may be appreciated,stretching in this manner can limit flow to a certain extent, but someminute fluid flow may continue even in the state presented in FIG. 10B.Deformation of tubing in this manner can cause wear on the tubing, so ahigh elasticity tubing may be employed to provide sufficient strengthand extension/contraction characteristics.

An alternate implementation is illustrated in FIGS. 11A and 11B,representing a hammer type design. From FIGS. 11A and 11B, a singlehammer 1101 may be used to deform tube 1105. FIG. 11A shows the hammertype control device 1100 deforming the tube 1105, while FIG. 11B showsthe hammer type control device 1100 in a nonextended state. The hammer1101 may be actuated by movable element 1102 which slides through smallsleeve 1103 and larger sleeve 1104. The movable element 1102 forces thehammer 1101 through a plate 1106 to deform tube 1105. A support member1107 may be provided to establish resistance for the tube 1105. FIG. 12Ashows a slidable single element 1201 deforming a tube 1205 while FIG.12B shows such the slidable single element 1201 in a non-deformingstate.

FIGS. 13A and 13B show a dual hammer approach similar to the device ofFIGS. 12A and 12B, with a dual hammer control device 1300 comprisingfirst hammer 1301 and second hammer 1302 used to deform tubing 1305.Ability to bind the tubing at two points can provide quicker responseand more accurate inhibition of fluid flow and may be preferable incertain applications. FIGS. 14A and 14B show an alternate construct of ahammer design similar to that presented in FIGS. 11A and 11B. Again,FIG. 14A shows the hammer type control device 1400 deforming the tube1405, while FIG. 14B shows the hammer type control device 1400 in anonextended state. The hammer 1401 may be actuated by movable element1402 which slides through small sleeve 1403 and larger rounded sleeve1404. The movable element 1402 again forces the hammer 1403 through aplate 1406 to deform tube 1405. A support member 1407 may be provided toestablish resistance for the tube 1405.

All of the foregoing control devices and any logical extensions, altereddesigns, or variations thereof may provide the ability to permit andrestrict irrigation and/or aspiration at a very high rate. In certainapplications, the foregoing designs may provide flow interruption andinitiation at a periodic rate of as low as less than or approximately 2to 100 milliseconds.

In operation, the system may use the aspiration control unit and/orirrigation control unit or device to produce a pulse pressured wave thatassists in acquiring and fixing tissue on the handpiece tip. Uponinitiation of ultrasonic action, instantaneous repellant forces andchatter from the ultrasonically driven handpiece tip can be overcome bya single or multiple micropressure wave transmission which tend(s) topropagate within the aspirating tubing and retract the tissue toward thehandpiece tip. The micropressure wave may be used prior to inception orformation of the cavitation field and may continue in concert with themodulated ultrasonic action.

Alternately, the system may employ the pulsed pressure wave generated byone of the aforementioned control devices to disrupt the cavitationcloud. A series of high frequency pulses are employed to disrupt thecavitation cloud. The system uses a series of high frequency fluidpulses to encourage collapse of the field and improve reacquisition oftissue on the distal end of the handpiece tip. Pulses may vary infrequency and duration, but as noted, the fluid pulses may be in therange of approximately 2 to 100 milliseconds long.

The system may also use micropressure waves to dislodge or realignfragmented particulates within the aspiration lumen. The aspirationlumen is the lumen or narrow passageway used in the handpiece to collectfluid from the affected area or region. The system generates vibratorypressure waves terminating at the tip, thereby creating a lubricioussurface and reducing the effective surface tension within the tubing andparticularly the small piece that is with the eye. Alternately, thesystem may achieve high vacuum levels by controlling flow and resultantsurge created by a given high vacuum level. The source can be vacuumbased and may regulate flow by the pressure pulse frequency and dutycycle.

As may be appreciated by those skilled in the art, various fluid pulsetiming schemes and associations with ultrasonic power delivery timingsequences may be employed. The goal of varying the time and power is toattain transient cavitation in a relatively rapid manner and enableacquisition of material in the environment presented without generatingsignificant heat. Timing of the fluid pulses may be coordinated with theultrasonic power delivery timing or may be different depending oncircumstances. For example, ultrasonic power delivery may include a twostep modulated pulse including providing a pulse of energy at level Xfor M ms, followed by a pause or de minimis power application for N ms.Fluid may be supplied at the same M and N timing scheme, or at a fluidpulse on for 2*M ms and off for N ms, or on for P ms and off for Q ms.Additionally, multiple levels of power may be applied, such as oneperiod at level X, one period at level Y, and one period at level Z,followed by a pause. The duty cycle, period, power level, and fluidlevel for the system may vary depending on circumstances.

While various timing sequences may be employed, it is generallyunderstood that fluid irrigation pulses have duration generally lessthan 100 ms when operating in accordance with the present design. Incertain circumstances and in certain environments, this number may be inthe range of 25, 20, 8, or even 2 ms. In transmitting certain pulseschemes, such as those required to facilitate transient cavitation, arelatively high amplitude pulse may be delivered for in the range ofgenerally less than approximately 25 ms, and in certain scenarios andenvironments, less than 10, 5, or even 2 ms. Aspiration by means ofapplication of negative pressure differential pulses may be for similarperiods, and generally operates in the range of less than 100 ms.

The present phacoemulsification system is set up to address occlusionsusing both modulated energy delivery and modulated energy delivery incombination with altered fluid delivery. With reference to FIG. 15,there is shown a flow diagram depicting basic control of the ultrasonicpower source 16 to produce varying pulse duty cycles as a function ofselected power levels. Each power pulse may have a duration of less than20 milliseconds. As shown in FIG. 5, and by way of illustration only, a33% pulse duty cycle is run until the power level exceeds a presetthreshold; in this case, 33%. At that point, the pulse duty cycle isincreased to 50% until the ultrasonic power level exceeds a 50%threshold, at which point the pulse duty cycle is increased to 66%. Whenthe ultrasonic power level exceeds 66% threshold, the power source isrun continuously, i.e., a 100% duty cycle. Although the percentages of33, 50 and 66 have been illustrated in FIG. 15, it should be understoodthat other percentage levels can be selected as well as various dutycycles to define different duty cycle shift points. The pulse durationin this arrangement may be less than 20 milliseconds. This control alongwith the tracking mechanism herein described enables bursts of energyless than 20 milliseconds in duration. With reference to FIG. 15, if thehandpiece aspiration line 38 is occluded, the vacuum level sensed by thevacuum sensor 24 will increase. Irrigation may be supplied by one or twoor more sources. The computer 18 has operator-settable limits forcontrolling which of the irrigation fluid supplies 32, 33 will beconnected to the handpiece 30. While two irrigation fluid sources, orcontainers 32, 33 are shown, any number of containers may be utilized.

As shown in FIG. 16, when the vacuum level by the vacuum sensor 24reaches a predetermined level, as a result of occlusion of theaspiration handpiece line 38, the computer further controls the valve 38causing the valve to control fluid communication between each of thecontainers 34, 35 and the handpiece/needle 30.

Depending upon the characteristics of the material occluding thehandpiece/needle 30, as herein described and based on the needs andtechniques of the physician, the pressure and fluid pulse period andpulse duty cycle of irrigation fluid provided to the handpiece may beincreased or decreased. As occluded material is cleared, the vacuumsensor 24 may register a drop in the vacuum level causing the valve 38to switch to a container 34, 35, providing pressure at an unoccludedlevel.

In addition to changing phacoemulsification handpiece/needle 30parameters as a function of encountered vacuum level, the occluded orunoccluded state of the handpiece can be determined and addressed basedon a change in load sensed by a handpiece/needle by way of a change inphase shift or shape of the phase curve. A plot of phase angle as afunction of frequency is shown in FIG. 17 for various handpiece 30loading, a no load (max phase), light load, medium load and heavy load.

With reference to FIG. 18, representing max phase mode operation, theactual phase is determined and compared to the max phase. If the actualphase is equal to, or greater than, the max phase, normal aspirationfunction is performed. If the actual phase is less than the max phase,the aspiration rate is changed, with the change being proportionate tothe change in phase. FIG. 19 represents operation at less than max loadin which load (see FIG. 17) detection is incorporated into theoperation.

As represented in FIG. 18, showing max phase mode operation, if thehandpiece aspiration line 40 is occluded, the phase sensed by phasedetector sensor 28 will decrease (see FIG. 17). The computer 18 providesoperator-settable limits for aspiration pulse rates, vacuum levels andultrasonic power levels. As illustrated in FIG. 18, when the phasesensed by phase detector 28 reaches a predetermined level as a result ofocclusion of the handpiece aspiration line 40, computer 18 instructspump speed controller 20 to change the speed of the peristaltic pump 14which, in turn, changes the aspiration rate and/or aspiration pulserate.

Depending upon the characteristics of the material occludinghandpiece/needle 30, the speed of the peristaltic pump 14 can either beincreased or decreased. When the occluding material is broken up, thephase detector 28 registers an increase in phase angle, causing computer18 to change the speed of peristaltic pump 14 to an unoccluded operatingspeed.

In addition to changing the phacoemulsification parameter of aspirationrate or aspiration pulse rate by varying the speed of the peristalticpump 14, the power level and/or duty cycle of the ultrasonic powersource 16 can be varied as a function of the occluded or unoccludedcondition of handpiece 30 as hereinabove described.

From the foregoing, depending on output conditions, cavitation may begenerated in different circumstances by the ultrasonic device, andcavitation inducing energy may be employed with pulsed fluidapplication. This cavitation and pulsed fluid application may beemployed in varying environments in addition to those disclosed herein,including but not limited to a diagnostic environment and a chemicalprocessing environment. The cavitation and pulsed fluid application mayalso be employed in medical treatments or to enhance medical treatments.Enhancement of medical treatments may include, for example, assisting oraccelerating the medical treatment. With respect to chemical processing,applying energy and fluid in the manner described can have a tendency tominimize heat resulting from ultrasound energy transmission, and cantend to minimize input energy required to effectuate a given chemicalresult.

Transient cavitation tends to require certain specific conditions tooccur effectively in the phaco environment, including but not limited tothe availability of properly sized initial bubbles and/or dissolved gasin the fluid. When bubbles of the proper size and/or dissolved gas arenot available, either because of low flow or in the presence of a highoutput level in a continuous power application mode, transientcavitation tends to transition to stable cavitation. Pulsing energy andfluid as opposed to constant energy and fluid can provide certainadvantages, such as enabling the fluid to resupply properly sizedbubbles to facilitate transient cavitation, consuming and deliveringless total power with less likelihood of causing thermal damage totissue.

The pulsing of energy and fluid described herein may be performed insoftware, hardware, firmware, or any combination thereof, or using anydevice or apparatus known to those skilled in the art when programmedaccording to the present discussion. A sample block diagram of theoperation of the pulsed energy and pulsed fluid aspect of the system asmay be implemented in software is presented in FIG. 20. From FIG. 20,after evaluating whether pulse mode has been enabled, the systemevaluates whether enhanced pulse mode has been enabled. If not, thesystem proceeds according to FIG. 21.

If enhanced pulse mode has been enabled, the Settings Required arereceived. Settings Required may include, but are not limited to, overallcycle time, a desired procedure or function to be performed (sculpting,chopping, etc.), desire to provide bursts or long continuous periods ofpower application, desired transient cavitation energy applicationamplitude, desired transient cavitation energy application period,desired lower amplitude energy level, desired lower amplitude energyduration, pause between transient application energy bursts, fluid pulseduration, fluid pulse duty cycle, fluid amplitude, fluid pause duration,and/or other pertinent information. Certain lookup tables may beprovided in determining Settings Required, including but not limited totables associating popular settings with the specific performanceparameters for the desired setting. For example, if the desired functionis “chop,” the system may translate the desired “chop” functionselection into a standardized or predetermined set of performanceparameters, such as a 150 millisecond ultrasonic energy “burst on”period, followed by an 350 ms “long off period,” and an associated 100millisecond fluid pulse on period followed by a 200 millisecond fluidpulse off period. The system takes the Settings Required and translatesthem into an Operation Set, or operation timing set, the Operation Setindicating the desired operation of the phacoemulsification handpiecetip when performing ultrasonic energy or power delivery as well as fluidapplication.

Input 2002 represents an optional input device, such as a foot pedal,electronic or software switch, switch available on thephacoemulsification handpiece, or other input device known to thoseskilled in the art, that allows the surgeon/operator to engage andenable ultrasonic power and fluid to be applied according to theOperation Set. For example, a foot pedal may be supplied that issues anon/off command, such that when depressed power and fluid are to beapplied according to the Operation Set, while when not depressed poweris not supplied to the phacoemulsification handpiece tip and fluid isapplied at a predetermined constant flow rate.

Different input devices may enable different modes of operation. Forexample, a multiple position switch may be provided that allows forapplication of ultrasonic power and fluid according to one OperationSet, while moving the switch to another position allows for applicationof ultrasonic power and fluid according to a different Operation Set.Alternately, one position of the switch may allow for power applicationand fluid at one level according to one Operation Set, while anotherposition of the switch may enable a higher ultrasonic power level anddifferent fluid level having the same or a different operational timingset. Operation Set as used herein refers to the timing of ultrasonicenergy pulses, energy applications, fluid applications, and/or on/offperiods for the application of power and fluid as described herein.Switching may also be nonlinear, such as one detent or setting for theswitch providing only pulsed irrigation to the handpiece 30, a seconddetent or setting providing a pump on plus pulsed irrigation, and athird detent or setting providing irrigation and aspiration whereinultrasound is introduced and may be increased by applying furtherengagement of the switch or foot pedal. In this instance, a foot pedaldepressed to the third position or detent will enable the operator orsurgeon to apply energy according to a base operational timing set andamplitude, such as a first operational timing set with a first transientcavitation inducing amplitude, while further depression of the footpedal would allow application of a second operational timing set and/ora second amplitude. If increased energy or fluid amplitude is desired,depressing the foot pedal past the third detent may linearly change theamplitude from a value of 0% of available ultrasonic power or tip strokelength as well as fluid pulse level to a value of 100% of ultrasonicpower/tip stroke length and fluid pulse level, or some other valuebetween 0% and 100%.

As may be appreciated, virtually any Operation Set and operation timingset may be employed while within the course and scope of this invention.In particular, the system enables operation in multiple configurationsor operational timing sets, each typically accessible to the user viathe computer. For example, the user may perform a chop operation usingone operational timing set, a sculpt operation using another operationaltiming set, and when encountering particular special conditionsemploying yet another operational timing set. These configurations mayoperate dynamically, or “on the fly.”

The system typically has a frame rate, which may be any period of timeless than the smallest allowable power on/power off period or fluidon/fluid off period for the device. A counter counts the number ofpulses, and if the Operation Set dictates that ultrasonic power or fluidis to be delivered at a certain frame number, an indication in the formof an electronic signal is delivered to the handpiece tip at that frametime. Other implementations beyond that shown in FIG. 20 may be employedwhile still within the scope of the present invention.

It will be appreciated to those of skill in the art that the presentdesign may be applied to other systems that perform tissue extraction,such as other surgical procedures used to remove hard nodules, and isnot restricted to ocular or phacoemulsification procedures. Inparticular, it will be appreciated that any type of hard tissue removal,sculpting, or reshaping may be addressed by the application of pulsedfluid in the manner described herein.

Although there has been hereinabove described a method and apparatus forproviding modulated fluid to a phacoemulsification handpiece utilizing afluid control device, for the purpose of illustrating the manner inwhich the invention may be used to advantage, it should be appreciatedthat the invention is not limited thereto. Accordingly, any and allmodifications, variations, or equivalent arrangements which may occur tothose skilled in the art, should be considered to be within the scope ofthe present invention as defined in the appended claims.

What is claimed is:
 1. An apparatus comprising: a handpiece having aneedle and electrical means for ultrasonically vibrating said needle; apower source configured to provide pulsed electrical power to thehandpiece; a controller configured to enable an operator to select andcontrol an amplitude of electrical pulses provided by the power source;and an irrigation control device configured to aspirate fluid during asurgical procedure conducted in a surgical environment, said irrigationcontrol device configured to receive fluid during at least one modulatedfluid burst period, said modulated fluid burst period comprising anegative pressure differential pulse delivered to the surgicalenvironment, followed by a de minimis pressure differential pulsetransmission.
 2. The apparatus of claim 1, said irrigation controldevice comprising a fluid control device providing an ability tomodulate pressure differential pulses having duration less than 100milliseconds.
 3. The apparatus of claim 1, wherein said controlleroperates in conjunction with the irrigation control device to enhanceeffects of a surgical procedure.
 4. The apparatus of claim 3, whereinenhancing effects of the surgical procedure comprises improvingacquisition and removal of tissue during the surgical procedure.
 5. Theapparatus of claim 3, wherein enhancing effects of the surgicalprocedure comprises enhancing effects from cavitation forces encounteredduring the surgical procedure.
 6. The apparatus of claim 1, wherein saidirrigation control further provides a subsequent nonzero pressuredifferential pulse.
 7. The apparatus of claim 6, wherein amplitude ofsaid subsequent nonzero pressure differential pulse materially differsfrom amplitude of said pressure differential pulse.
 8. The apparatus ofclaim 6, wherein amplitude of said subsequent nonzero pressuredifferential pulse is substantially identical to amplitude of saidpressure differential pulse.
 9. The apparatus of claim 35, wherein thepulse produced by the irrigation control device has a duration of atmost approximately 25 milliseconds.
 10. The apparatus of claim 35,wherein the pulse produced by the irrigation control device has aduration of at most approximately 8 milliseconds.